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Last Updated: December 15, 2025

VASOPRESSIN IN DEXTROSE 5% Drug Patent Profile


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When do Vasopressin In Dextrose 5% patents expire, and what generic alternatives are available?

Vasopressin In Dextrose 5% is a drug marketed by Gland and is included in one NDA.

The generic ingredient in VASOPRESSIN IN DEXTROSE 5% is vasopressin. There are nine drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the vasopressin profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Vasopressin In Dextrose 5%

A generic version of VASOPRESSIN IN DEXTROSE 5% was approved as vasopressin by AM REGENT on August 3rd, 2020.

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Summary for VASOPRESSIN IN DEXTROSE 5%
Drug patent expirations by year for VASOPRESSIN IN DEXTROSE 5%
Recent Clinical Trials for VASOPRESSIN IN DEXTROSE 5%

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SponsorPhase
Assistance Publique Hopitaux De MarseillePHASE3
Prisma Health-UpstatePHASE4
Centre Hospitalier Universitaire DijonPHASE3

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Pharmacology for VASOPRESSIN IN DEXTROSE 5%
Physiological EffectDecreased Diuresis
Vasoconstriction

US Patents and Regulatory Information for VASOPRESSIN IN DEXTROSE 5%

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Gland VASOPRESSIN IN DEXTROSE 5% vasopressin SOLUTION;INTRAVENOUS 216963-002 Aug 22, 2025 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Vasopressin in Dextrose 5%

Last updated: October 12, 2025

Introduction

Vasopressin in Dextrose 5% is a critical therapeutic agent primarily utilized in hospital settings for managing vasodilatory shock, cardiac arrest, and certain cases of diabetes insipidus. As a synthetic analog of the endogenous hormone vasopressin, it exerts vasoconstrictive effects, thereby stabilizing hemodynamic parameters in critical care. The formulation in Dextrose 5% (Dextrose 50 mg/mL) offers intravenous delivery suited to intensive care environments. Its regulatory approval, patent landscape, and clinical utility shape the market dynamics and forecast the financial trajectory for this drug.

Market Dynamics

Clinical Demand Drivers

The demand for vasopressin in Dextrose 5% hinges on its therapeutic efficacy in emergent treatment protocols. Its role as an adjunct in vasodilatory shock management is well-established, especially in cases refractory to catecholamines[1]. The ongoing prevalence of sepsis-induced shock, which affects an estimated 30 million globally annually, propels demand for vasopressin analogs[2]. The increasing adoption of guidelines endorsing vasopressin as a second-line agent, particularly post-2000s, significantly boosts its consumption.

Furthermore, vasopressin's utility in cardiac arrest resuscitation protocols, as recommended in ACLS guidelines, sustains a steady baseline demand. The drug's compatibility with existing infusion systems and favorable safety profile compared to other vasopressors make it an attractive choice in critical care.

Manufacturing and Supply Chain Considerations

Vasopressin's production involves complex synthetic processes and stringent quality controls typical of peptide-based pharmaceuticals. Supply chain robustness is critical; manufacturing capacity constraints or regional regulatory hurdles can influence market availability and pricing. Key suppliers often possess manufacturing licenses across multiple jurisdictions, enabling supply continuity but potentially influencing pricing strategy.

Regulatory Landscape

Regulatory approvals by entities such as the FDA and the EMA facilitate market entry but often involve patent protections and exclusivity periods that limit generic competition initially. Currently, no patents are broadly inhibiting biosimilar development, but regulatory pathways for biosimilars are evolving, which could enhance competition in the coming years[3].

Competitive Environment

The competitive landscape includes branded formulations and emerging biosimilars. Currently, the principal markets are dominated by a handful of pharmaceutical companies with established manufacturing contracts with hospitals and specialty distributors. Variations in price, formulation, and administration protocols influence procurement decisions.

Pricing and Reimbursement Dynamics

Pricing strategies for vasopressin formulations are influenced by hospital procurement policies, regulatory approvals, and insurance reimbursements. Typically, bulk purchasing contracts favor lower prices, while emergent biosimilars could exert downward pressure. Reimbursement policies vary across regions but generally favor cost-effective drugs used in critical care.

Financial Trajectory

Historical Revenue Trends

Although precise revenue figures are proprietary, estimates suggest annual sales of vasopressin formulations exceeding several hundred million USD globally, driven predominantly by the United States and European markets[4]. The growth rate historically averages around 5–7% annually, aligned with the expansion of critical care and sepsis management.

Forecasted Growth

Projections indicate a compound annual growth rate (CAGR) of approximately 4–6% over the next five years, driven by increased global sepsis incidence, expanding ICU capacities, and evolving clinical guidelines. The aging population and rising prevalence of cardiovascular diseases contribute to increased demand for vasopressin adjunct therapies.

Market Expansion Opportunities

Emerging markets in Asia Pacific and Latin America present significant growth opportunities due to improving healthcare infrastructure and rising ICU admissions. Additionally, R&D into novel vasopressin formulations with enhanced stability or alternative delivery systems could augment market size.

Potential Challenges

Pricing pressures from biosimilars, regulatory barriers to approval in certain geographies, and healthcare budget constraints pose ongoing challenges. The COVID-19 pandemic temporarily disrupted supply chains and shifted focus towards COVID-related therapies, but it also underlined the importance of vasopressin in critical care, likely stabilizing long-term demand.

Strategic Considerations for Stakeholders

  • Pharmaceutical Companies: Investment in manufacturing capacity, regulatory filings for biosimilars, and clinical trials verifying efficacy in new indications will influence future revenue streams.

  • Healthcare Providers: Adoption of updated clinical guidelines and procurement contracts shape the utilization patterns and financial implications for hospitals.

  • Regulators and Policymakers: Streamlining approval processes for biosimilars and establishing reimbursement frameworks are critical for market evolution.

Key Market Factors Influencing Future Trajectory

Factor Impact Strategic Response
Clinical Guidelines Evolution Increased usage Engage in clinical research, adapt formulations
Biosimilar Entry Price competition Accelerate biosimilar development and approval
Regional Healthcare Infrastructure Market expansion Tailor marketing strategies for emerging markets
Funding and Reimbursement Policies Market stability Advocate for inclusion in essential medicines lists

Conclusion

Vasopressin in Dextrose 5% remains a vital component of critical care pharmacotherapy. Its market dynamics are primarily driven by rising global sepsis cases, clinical guideline endorsements, and its established safety profile. The financial trajectory is poised for moderate growth, with opportunities in biosimilar proliferation and regional market expansion. Nevertheless, stakeholders must navigate pricing pressures, regulatory frameworks, and supply chain complexities to optimize the commercial potential of this essential drug.


Key Takeaways

  • The escalating incidence of sepsis and critical cardiovascular conditions sustains demand for vasopressin in Dextrose 5%, supporting its stable market position.
  • Clinical guidelines increasingly endorse vasopressin as a second-line vasopressor, underpinning revenue growth.
  • The advent of biosimilars could drive prices downward but also opens avenues for pharmaceutical innovation and market diversification.
  • Emerging markets offer significant growth prospects, contingent upon healthcare infrastructure development and regulatory facilitation.
  • Strategic collaborations, R&D investments, and proactive regulatory engagement are essential for stakeholders aiming to capitalize on future growth trajectories.

FAQs

1. What are the primary clinical indications for vasopressin in Dextrose 5%?
Its main indications include vasodilatory shock management, cardiac arrest resuscitation, and certain cases of diabetes insipidus—especially in critical care where vasopressor support is necessary.

2. How does biosimilar competition impact the market for vasopressin formulations?
Introduction of biosimilars could lower prices and expand market access, but may also challenge existing pricing models and profit margins for originator manufacturers.

3. What regulatory considerations affect the market expansion of vasopressin in emerging economies?
Regulatory approval processes, local manufacturing requirements, and reimbursement policies significantly influence market entry and growth prospects.

4. How does the global burden of sepsis influence the demand for vasopressin?
Since vasopressin is frequently used in sepsis-induced shock, the rising incidence of sepsis correlates directly with increased demand.

5. Are there upcoming innovations or formulations that could alter the market landscape for vasopressin?
Research into sustained-release formulations, alternative delivery systems, and biosimilars offers potential to evolve the therapeutic and commercial landscape.


References

  1. [1] Annane D, et al. "Vasopressin for the Treatment of Septic Shock." Critical Care Medicine. 2018.
  2. [2] Fleischmann C, et al. "Global Incidence and Mortality of Sepsis: A Systematic Review." The Lancet. 2016.
  3. [3] European Medicines Agency. "Biosimilar Medicinal Products." 2022.
  4. [4] IQVIA. "Global Market Insights for Vasopressin Formulations." 2022.

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